title: Randomised clinical trial: twice daily esomeprazole 40 mg vs. pantoprazole 40 mg in Barrett's oesophagus for 1 year.
abstract: BACKGROUND
  Barrett's oesophagus is regarded as the most important risk factor for development of oesophageal adenocarcinoma. According to current guidelines, treatment should be limited to symptomatic Barrett's oesophagus.
  
  
  OBJECTIVE
  To evaluate the expression of Ki67, cyclooxygenase-2 (COX-2) and apoptosis in Barrett's oesophagus after 12 months of double-dose proton pump inhibitor therapy. The effectiveness of esomeprazole and pantoprazole was also compared.
  
  
  METHODS
  Seventy-seven nondysplastic Barrett's oesophagus patients underwent baseline upper endoscopy. Patients were then randomised into two groups: one group was allocated to receive esomeprazole 40 mg b.d. and the other group pantoprazole 40 mg b.d. for 12 months. A follow-up endoscopy was performed at the end of treatment. Sixty-five of 77 patients agreed to undergo oesophageal manometry and 24-h pH-metry. Barrett's oesophagus biopsies, obtained at baseline and after treatment, were analysed using immunohistochemistry to assess Ki67 and COX-2 expression; apoptosis was evaluated using TUNEL.
  
  
  RESULTS
  In the esomeprazole group, a significant decrease in Ki67 and COX-2 expression, as well as an increase in apoptosis, were observed (P < 0.05). By contrast, in the pantoprazole group Ki67, COX-2 and apoptosis did not vary significantly from baseline. By 24-h oesophageal pH-monitoring, a normal acid exposure time was recorded in patients treated with esomeprazole, while those allocated to pantoprazole displayed abnormal acid exposure (P < 0.05).
  
  
  CONCLUSIONS
  Treatment of Barrett's oesophagus patients with high-dose esomeprazole, but not pantoprazole, promoted a decrease in proliferative markers, concomitantly with a decrease in apoptotic cell death. Moreover, esomeprazole allowed a better oesophageal acid control than pantoprazole.
authors.affiliation: Gastroenterology Unit, Department of Internal Medicine, University of Pisa, Italy.
authors.forename: N
authors.initials: N
authors.lastname: de Bortoli
authors.forename: I
authors.initials: I
authors.lastname: Martinucci
authors.forename: P
authors.initials: P
authors.lastname: Piaggi
authors.forename: S
authors.initials: S
authors.lastname: Maltinti
authors.forename: G
authors.initials: G
authors.lastname: Bianchi
authors.forename: E
authors.initials: E
authors.lastname: Ciancia
authors.forename: D
authors.initials: D
authors.lastname: Gambaccini
authors.forename: F
authors.initials: F
authors.lastname: Lenzi
authors.forename: F
authors.initials: F
authors.lastname: Costa
authors.forename: G
authors.initials: G
authors.lastname: Leonardi
authors.forename: A
authors.initials: A
authors.lastname: Ricchiuti
authors.forename: M G
authors.initials: MG
authors.lastname: Mumolo
authors.forename: M
authors.initials: M
authors.lastname: Bellini
authors.forename: C
authors.initials: C
authors.lastname: Blandizzi
authors.forename: S
authors.initials: S
authors.lastname: Marchi
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D017209:Apoptosis / Q000187:drug effects; D001471:Barrett Esophagus / Q000188:drug therapy*; D049109:Cell Proliferation / Q000187:drug effects; D052246:Cyclooxygenase 2 Inhibitors / Q000378:metabolism; D064098:Esomeprazole / Q000008:administration & dosage*; D050782:Esophageal pH Monitoring; D005260:Female; D006801:Humans; D019394:Ki-67 Antigen / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D000077402:Pantoprazole; D054328:Proton Pump Inhibitors / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D052246:Cyclooxygenase 2 Inhibitors; D019394:Ki-67 Antigen; D054328:Proton Pump Inhibitors; D000077402:Pantoprazole; D064098:Esomeprazole